The field of this invention is achievement of improved palatability of compositions containing high-viscosity cellulose ethers of a specific particle-size distribution and the use of such compositions for reducing the serum cholesterol level of an animal.
The use of cellulose ethers in edible compositions and, in particular, pharmaceutical products, is well known. A common function of the cellulose ether in such uses is to serve as a controlled release agent. Typically, only minimal quantities, representing only a small percentage of a total formulation, of the cellulose ether are required in such uses.
A variety of compounds are currently known to be useful in reducing serum cholesterol levels in humans. However, many of these compounds, including both systemic and non-systemic compounds, have undesirable side effects or have certain characteristics that lead to difficulties in patients complying with their use. For example, characteristics such as the sandiness, grittiness, throat irritation, dispersion difficulties and phase separation of known compounds leads to very poor patient compliance. Accordingly, the search for new non-systemic compounds useful in reducing serum cholesterol levels in humans continues to be an important field of research.
Cholestyramine is an important, non-systemic compound known to be effective in treating high blood cholesterol levels, also known as hypercholesterolemia, which are believed to be responsible in many cases for arteriosclerosis in humans. Cholestyramine, which is typically orally consumed in order to effect its cholesterol lowering or controlling properties, is astringent and unpleasant to swallow. The cholestyramine also has the side effect of inducing constipation. Processes and compositions including cholestyramine are known, such as those described in U.S. Pat. Nos. 3,308,020; 3,383,281; 3,499,960; and 3,947,272.
It is known that soluble vegetable fibers such as psyllium, guar, and .beta.-glucans may exert cholesterol lowering effects, but these soluble fibers are not very efficacious on a per gram basis. Also, because soluble vegetable fibers are easily metabolized by colonic bacteria (causing extensive anaerobic production of methane, carbon dioxide, and hydrogen), these vegetable fibers are known to cause gross flatulence, bloating and grave abdominal discomfort when administered in therapeutically effective doses. Furthermore, psyllium seed husk is typically contaminated with proteinaceous hull which carries the allergens known to be associated with psyllium.
Ground psyllium seed is recognized for its ability to lower serum cholesterol levels in human patients. EP-A-0362926 describes the use of products containing psyllium seed husk to be effective in reducing human serum cholesterol levels and in controlling blood glucose levels in diabetics.
EP-A-0309029 describes cookies containing psyllium and polyol polyesters which are useful in reducing blood cholesterol levels.
EP-A-0323666 describes the use of products containing cholestyramine in combination with psyllium or with polyol polyesters as orally administered cholesterol-lowering compositions.
Evidence of the unpalatability of compositions currently being marketed to treat hypercholesterolemia is the low rate of compliance by human patients to adhere to diets requiring daily consumption of these compositions. This low compliance rate indicates a definite need for a hypocholesteremia-controlling composition which is more palatable and more effective than the known compositions.
The present invention solves some of the above problems by disclosing a composition which is useful in a method for reducing serum cholesterol levels in human patients. Such compositions are more palatable and more effective than known compositions.